Notified Body Procedures 1024

Procedure for Testing and Certification of PPE

1. The manufacturer may request a partial test (it is recommended to discuss this in advance with the representative of the relevant laboratory – see contacts). The Test Request Form is used, which enables specification of the test.
2. For PPE testing and conformity assessment (certification), the client submits an Application for EU Type Examination. The application must specify the product category, protective properties, method of conformity assessment, etc. The client must also provide the required technical documentation (see Application Form, p. 2). It must be indicated whether the applicant is the manufacturer or an authorized representative, whether the documentation should also be delivered in electronic form (the certificate is always issued in printed form), and whether an English version of the certificate is required.
3. OS 1024 prepares a draft contract for EU type examination of PPE. This contract specifies, among other things, the scope of testing, subcontracting arrangements, deadlines, price, and the manufacturer’s commitment to the proper use of the certificate. The draft is sent to the client, who may comment on it. Following agreement with OS 1024, the contract may be amended and is then signed by both parties.
4. The client provides the required test samples in the agreed scope and completes the technical documentation according to the instructions of OS 1024. Where agreed, an advance payment for testing is made.
5. OS 1024 performs the tests, prepares a test report, and subsequently reviews the documentation and test results, issuing a Final Certification Report. The assessment outcome is communicated to the client together with a request for payment of certification costs.
6. Upon payment, OS 1024 provides the client with the test report, the final certification report, and, where the product meets the requirements of Regulation (EU) 2016/425, the EU type-examination certificate, which is valid throughout the EU.
7. Based on the product’s technical documentation, the test report, the final certification report, and the EU type-examination certificate, the manufacturer (or authorized representative) prepares the EU Declaration of Conformity. The CE marking, which must be affixed to every PPE, is then applied. For PPE in Category III, the CE marking must be accompanied by the identification number of the Notified Body conducting surveillance.
8. For Category III PPE, the manufacturer (or authorized representative) must, at regular annual intervals, request the selected Notified Body to perform surveillance according to either Module C2 or Module D. The resulting surveillance reports must be kept in the manufacturer’s (or importer’s) documentation, serving as a basis for the Declaration of Conformity. Failure to conduct these annual surveillance checks constitutes a serious breach of the manufacturer’s obligations. Without them, the manufacturer is not permitted to place the products on the market.
9. If the approved type is modified, the state of the art changes, or the certificate nears expiration (no earlier than 12 months and no later than 6 months before expiry), the manufacturer must apply for renewal of the EU type-examination certificate.
10. The client may appeal against the results of testing or certification within 15 days of the issuance, suspension, or withdrawal of a certificate, or the issuance of a test report or related documentation. Appeals must be submitted in writing, stating the reasons, and sent to OS 1024. Appeals and complaints are handled by the Head of OS within 30 days.